FDA (Drugs) recall action 90644
The FDA (Drugs) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Aire-Master of America is recalling Avant Foaming Hand Sanitizer due to a manufacturing process deviation where the deionized water system lacked proper microbial controls during production.
Protect U Guard Foaming Hand Sanitizer is being recalled due to a manufacturing deficiency in the deionized water system. The product was distributed in Florida, Illinois, Iowa, and New Jersey.
Aire-Master of America Inc is recalling Common Sense Fragrance Free Hand Sanitizer due to a manufacturing process deviation. The product was made using deionized water from a system that lacked appropriate microbial control.
Protect U Guard Foaming Hand Sanitizer is being recalled because it was manufactured with deionized water from a system lacking proper microbial controls. The affected product was distributed in Florida, Illinois, Iowa, and New Jersey.
Aire-Master of America Inc is recalling 4,632 cartons of Stage 2-Ophardt Foaming Hand Sanitizer due to manufacturing deviations in the water system's microbial control. Product was distributed in Florida, Illinois, Iowa, and New Jersey.
Aire-Master of America Inc. is recalling Avant Foaming Hand Sanitizer because the deionized water system used in manufacturing lacked appropriate microbial control measures.